FDA 510(k)

BSD4343 디지털 평면 X선探测器

K-번호: K160204 · 2016-06-09

결정일2016-06-09

제품 코드MQB

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

BSD4343 Digital Flat Panel X-ray Detector is the device name listed in this FDA 510(k) record. The listed applicant is Bontech, Inc.. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160204. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BSD4343 Digital Flat Panel X-ray Detector?

BSD4343 Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Bontech, Inc.. The 510(k) number is K160204.

When did BSD4343 Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?

BSD4343 Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160204.

Who is the listed applicant for BSD4343 Digital Flat Panel X-ray Detector?

The FDA 510(k) record lists Bontech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BSD4343 Digital Flat Panel X-ray Detector?

The FDA product code for BSD4343 Digital Flat Panel X-ray Detector is MQB.

Bontech, Inc.를 신청인으로 등재한 기타 기록

K171485BSD4343R 디지털 평면 X선探测器 K162487BSD3543 디지털 평면 X선探测器

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.